Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)

NCT ID: NCT05287919

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-01-31

Brief Summary

Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.

Objective: to compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.

Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were strength, functionality, independence for activities of daily living, quality of life, and total days hospitalized.

Detailed Description

Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.

Research question: The research question was is medium-frequency neuromuscular electrical stimulation (NMES) more effective than low-frequency NMES for the attenuation of skeletal muscle atrophy in critically ill patients?

Objective: To compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.

Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were muscle strength (MRC-SS), handgrip strength (dynamometry), functional status (FSS-ICU), degree of independence for activities of daily living (Barthel Index), functional mobility and dynamic balance (Timed Up and Go Test), quality of life (SF-36), and total days hospitalized.

Conditions

Critical Illness; Physical Disability; Muscle Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients received the standard physical therapy (SPT) programme only (passive mobilization) twice a day.

Group Type: OTHER

Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.

Intervention Type: OTHER

All participants have received standard physical therapy (SPT) sessions based on a passive range of motion mobilization protocol for the lower limbs. It consisted of a bilateral series of 10 repetitions of hip flexion, knee flexion and extension, and ankle flexion and extension. The procedure was performed twice a day: a morning (between 8am - 12pm) and an afternoon session (between 2pm - 6pm).

Low-frequency NMES group

Patients submitted to low-frequency NMES and SPT twice a day.

Group Type: EXPERIMENTAL

Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.

Intervention Type: OTHER

All participants have received standard physical therapy (SPT) sessions based on a passive range of motion mobilization protocol for the lower limbs. It consisted of a bilateral series of 10 repetitions of hip flexion, knee flexion and extension, and ankle flexion and extension. The procedure was performed twice a day: a morning (between 8am - 12pm) and an afternoon session (between 2pm - 6pm).

Patients received the low-frequency neuromuscular electrical stimulation (NMES)

Intervention Type: OTHER

Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands). The low-frequency protocol consisted of 100 Hz and 400 ms width pulses, delivered in trains of 5 s ON (ramp-up time: 1 s, plateau: 3 s, ramp-down time: 1 s) and 10 s OFF. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.

Medium-frequency NMES group

Patients submitted to medium-frequency NMES and SPT twice a day.

Group Type: EXPERIMENTAL

Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.

Intervention Type: OTHER

All participants have received standard physical therapy (SPT) sessions based on a passive range of motion mobilization protocol for the lower limbs. It consisted of a bilateral series of 10 repetitions of hip flexion, knee flexion and extension, and ankle flexion and extension. The procedure was performed twice a day: a morning (between 8am - 12pm) and an afternoon session (between 2pm - 6pm).

Patients received the medium-frequency neuromuscular electrical stimulation (NMES)

Intervention Type: OTHER

Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands).The medium-frequency protocol had similar parameters, but a carrier frequency of 2500 Hz and burst frequency of 100 Hz. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.

Interventions

Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.

All participants have received standard physical therapy (SPT) sessions based on a passive range of motion mobilization protocol for the lower limbs. It consisted of a bilateral series of 10 repetitions of hip flexion, knee flexion and extension, and ankle flexion and extension. The procedure was performed twice a day: a morning (between 8am - 12pm) and an afternoon session (between 2pm - 6pm).

Intervention Type: OTHER

Patients received the low-frequency neuromuscular electrical stimulation (NMES)

Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands). The low-frequency protocol consisted of 100 Hz and 400 ms width pulses, delivered in trains of 5 s ON (ramp-up time: 1 s, plateau: 3 s, ramp-down time: 1 s) and 10 s OFF. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.

Intervention Type: OTHER

Patients received the medium-frequency neuromuscular electrical stimulation (NMES)

Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands).The medium-frequency protocol had similar parameters, but a carrier frequency of 2500 Hz and burst frequency of 100 Hz. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients between 18-80 years old admitted in ICU with requirement of mechanical ventilation (MV) for longer than 72 h.

Exclusion Criteria

• non-sedated patients;
• spinal cord injury;
• cerebrovascular accident;
• patients with pacemakers;
• history of deep vein thrombosis;
• pregnancy;
• cardiac complications (history of myocardial infarction or congenital diseases);
• use of neuromuscular blockers;
• polytraumatized patients requiring tutor support.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gabriel Nasri Marzuca-Nassr

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Nasri Marzuca-Nassr

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gabriel N Marzuca-Nassr,, PT, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Locations

Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera

Temuco, , Chile

Countries

Chile

References

Guerra-Vega P, Guzman R, Betancourt C, Grage M, Vera C, Artigas-Arias M, Munoz-Cofre R, Vitzel KF, Marzuca-Nassr GN. Medium-Frequency Neuromuscular Electrical Stimulation in Critically Ill Patients Promoted Larger Functional Capacity Improvement During Recovery than Low-Frequency Neuromuscular Electrical Stimulation: Randomized Clinical Trial. J Clin Med. 2025 Jul 31;14(15):5407. doi: 10.3390/jcm14155407.

Reference Type: DERIVED

PMID: 40807029 (View on PubMed)

Other Identifiers

Tesis UFRO #1676

Identifier Type: -

Identifier Source: org_study_id